Biomerica secures IVDR (In Vitro Diagnostic Regulation) certification, ensuring compliance with stringent European Union ...

Biomerica (BMRA) announces that its food intolerance products for Crohn’s Disease and Ulcerative Colitis have achieved CE-marking under the ...

Aiforia® Prostate Cancer Gleason 4 Cribriform and Perineural Invasion (PNI) AI models assist pathologists in detecting these patterns in whole slide images (WSI) of prostate tissue. These AI models ...

BIOHIT OYJ is excited to announce the launch of the BIOHIT FAEX Sample System, a revolutionary stool sample collection and ...

After several high-profile scandals surrounding medical devices, where irresponsible manufacturers’ malpractice in cutting corners showed how easy it was to abuse the Directive, the IVDR came ...

"Net sales increased during the fourth quarter by 41.5 percent to SEK 64.2 million, compared with the corresponding quarter of 2023. The growth and strong performance are a result of robust developmen ...

Devyser a leading provider of genetic testing solutions, has been awarded a significant tender for the supply of its comprehensive next-generation sequencing (NGS) tests for critical genetic markers.

Its seamless integration with existing systems enables laboratories to boost productivity and meet important regulatory standards, including Europe’s CE-IVD and IVDR requirements. Innovation at ...

AliveDx seeks US FDA 510(k) premarket approval for MosaiQ AiPlex CD multiplex microarray: Eysins, Switzerland Tuesday, February 11, 2025, 12:00 Hrs [IST] AliveDx, an established c ...

Ikeda's expertise includes FDA and EU submissions for the IVD industry, such as 510(k), premarket approval (PMA), PMA supplements, annual reports, and Class D IVDR dossiers.

AliveDx has obtained a CE mark under the EU's in vitro diagnostic regulation (IVDR) for the AiPlex connective tissue disease (CTDplus) multiplex assay for use with its MosaiQ planar microarray ...